MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRAPEZOID RX; LITHOTRIPTOR, BILIARY MECHANICAL

Model Number M00510880

Device Problem Premature Activation (1484)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/26/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a trapezoid rx lithotripter basket was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, an alliance handle was utilized in conjunction with the trapezoid basket to crush a 1 cm gallstone.However, the basket's tip prematurely disengaged, and the tip could not be recovered.The treatment was finished by slightly compressing the gallstones, extracting the stones with a balloon, and using a flexima.There were no patient complications as a result of this event.

Manufacturer Narrative

Imdrf device code a150103 captures the reportable event of tip prematurely deployed.

Event Description

It was reported that a trapezoid rx lithotripter basket was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, an alliance handle was utilized in conjunction with the trapezoid basket to crush a 1 cm gallstone.However, the basket's tip prematurely disengaged, and the tip could not be recovered.The treatment was finished by slightly compressing the gallstones, extracting the stones with a balloon, and using a flexima.There were no patient complications as a result of this event.

Manufacturer Narrative

Block h6: imdrf device code a150103 captures the reportable event of tip prematurely deployed.Block h10: the returned trapezoid rx basket was analyzed, and a visual evaluation noted that the tip was detached from the basket assembly.However, it should be noted that the tip was not returned with the device for further analysis.Additionally, the thumb ring of the device was found to be detached upon its return.The reported event was confirmed.Based on all available information and the observed condition of the device, it is likely that the detachment of the tip was intentional and a feature of the device.In cases where the calculi cannot be crushed, the basket tip is designed to disengage to prevent further damage.Therefore, this occurrence aligns with the intended functionality of the device, as stated in the instructions for use (ifu).Furthermore, it is plausible that during the procedure, manipulation or technique employed to remove the device from the scope resulted in the detachment of the thumb ring.The thumb ring may have become dislodged as a consequence of the previous detachment of the tip.Considering the aforementioned factors, the root cause of the reported event is determined to be an adverse event related to procedure.

• Brand Name: TRAPEZOID RX
• Type of Device: LITHOTRIPTOR, BILIARY MECHANICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16958179
• MDR Text Key: 315862775
• Report Number: 3005099803-2023-02624
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296393
• UDI-Public: 08714729296393
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K040447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2023
• Device Model Number: M00510880
• Device Catalogue Number: 1088
• Device Lot Number: 0030717780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2023
• Initial Date FDA Received: 05/18/2023
• Supplement Dates Manufacturer Received: 06/06/2023
• Supplement Dates FDA Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1